COLT2 Pregnancy Data Collection - Initial Dataset in A Randomized, Double-Blind, Placebo Controlled Study of the Efficacy of Lithium for Treatment of Pediatric Mania followed by an Open Label Long-Term Safety Period, Double-Blind, Placebo-Controlled Discontinuation Phase and Open Label Restabilization Period

File contains no data; no pregnancies reported
Study Description
The second of two multiphase, multicenter trials that comprehensively examined lithium in the treatment of pediatric patients with bipolar I disorder. In the first phase, the Efficacy Phase, participants were randomized to either lithium or placebo for 8 weeks to determine efficacy. Eligible participants then continued in the Long-Term Effectiveness Phase for a maximum of 24 weeks of lithium treatment. Subsequently, participants meeting response criteria during the Long-Term Effectiveness Phase were eligible to continue in the Discontinuation Phase, when they were randomized to either placebo or lithium treatment for up to 28 weeks. Finally, those participants who experienced a mood relapse during the Discontinuation Phase were enrolled in an Open Label Restabilization Phase and treated with lithium for up to 8 weeks.
Children and adolescents 7-17 years of age who meet DSM-IV diagnostic criteria for bipolar I (mania, mixed mania) without psychotic symptoms as determined by a child and adolescent psychiatrist